An exceptional opportunity has arisen to provide Quality leadership within the purpose built Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC will produce sterile injectable medicinal products in line with MHRA Good Manufacturing Practice on behalf of the North East and North Cumbria Provider Collaborative.

The post holder will act as Deputy Head of Quality and will be responsible for assuring the quality of medicines, for all of the pharmaceutical quality systems across the MMC and the management of the Quality team.

Main duties of the job

To provide leadership on Quality related aspects within the MMC.

To meet clinical needs within the Integrated Care Services (ICS) for ready to use sterile injectable medicinal products.

To support the establishment of the MMC, as a leading Manufacturing Centre within the national NHS framework for aseptic transformation.

About us

The MMC is in the late stages of design, with the facility build phase planned through to September 2025. This presents an exciting opportunity to be involved in the design and build of a new facility, the development of new production process and contribution to establishing a functional PQS for the facility.

A successful candidate will be integral in establishing the quality team for the delivery of anti-cancer and ready-to-administer sterile medicines for use in all 8 acute NHS Trusts in the NENC region.

Staff will be employed by Northumbria Healthcare Foundation NHS Trust until the formation of the Medicines Manufacturing Centre Legal Liability Partnership (LLP) is formed as a legal entity, after which TUPE regulations will apply.

Job description

Job responsibilities

To act as deputy for the Head of Quality whereappropriate.

To provide leadership onQuality Assurance(QA)related aspects within the MMC.

To manageand trainthe team releasing products manufactured under the MHRA Specials Licence.

Implementqualitypolicies whichcomplies withGood Manufacturing Practice.

To lead in thereviewand approvalof user requirement specifications for manufacturing equipment.

To chair/sub-chairthe Quality Management Meeting leading and ensuringappropriate pharmaceuticalquality systems are in place in all departments of theMMC.

To lead on investigations involving the quality of pharmaceutical products across theMMC.

To perform QA Specialist functions, including external supplier audits, QA input into procurement, education and training, and advising colleagues in other Trusts in North East and North Cumbria.

Interview Information:

Candidates will be presented with a scenario before the interview, and allowed time to review and make notes which will be presented and discussed with the panel during interview.

Person Specification

Knowledge & Skills

Essential

• Masters degree in a scientific / engineering discipline
• Post graduate qualification in Pharmaceutical Analysis/Quality Assurance or equivalent experience
• Registered Professional with the General Pharmaceutical Council (GPhC) or, Academy for Healthcare Science (AHCS), or Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB) or Royal Pharmaceutical Society (RPS).
• Advanced theoretical and practical knowledge, gained through training, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines

Desirable

• Full Qualified Person eligibility (permanent provisions)
• Management qualification

Employer details

Employer name

Northumbria Healthcare NHS Foundation Trust

Address

MMC - Seaton Delaval Manufacturing Hub

Seaton Delaval

NE25 0QJ

Any attachments will be accessible after you click to apply.

319-6631208HD